New Method to Close Nasal Septal Perforation

NCT ID: NCT06439927

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasal Perforated Septum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Polycaprolactone nasal mesh

Group Type EXPERIMENTAL

Polycaprolactone nasal mesh

Intervention Type DEVICE

a 3-dimensional fabricated Polycaprolactone nasal mesh

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polycaprolactone nasal mesh

a 3-dimensional fabricated Polycaprolactone nasal mesh

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing nasal septal perforation repair surgery.

Exclusion Criteria

* Patients with known allergy to polycaprolactone.
* Pregnancy or lactation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helwan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Hossam Sebaey

Assistant lecturer of otorhinolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamed H Sebaey, master degree

Role: PRINCIPAL_INVESTIGATOR

Helwan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine, Helwan University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed H Sebaey, Master degree

Role: CONTACT

01008306356

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed H Sebaey, master degree

Role: primary

01008306356

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

self sponsored

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.